The American Optician

Spring 2017

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1 6 • Brand security • Guaranteed sell-through • Sold only through independent ECPs • One rep for all brands • Lifetime warranties 800.621.4108 e y e w e a r to various environments and their functional life expectancy. REGULATIONS Dress eyeglass manufacturers and processers must meet two U.S. Food and Drug Administration (FDA) regulations: Good Manufacturing Practices (CFR 21 C.F.R. 820) and Lens Impact Resistance (CFR21.801.410) . These are required because eyeglasses are classified as a class 1 medical device. Safety eyewear products must also meet OSHA (Occupational Safety and Health Administration) regulations. The FDA regulations state that all eyeglass lenses sold in the U.S. must be capable of meeting the FDA regulation's impact test. Click here to see the basic aspects of that test. OSHA requires employers to ensure that each affected employee uses appropriate eye or face protection when exposed to eye or face hazards from flying particles, molten metal, liquid chemicals, acids or caustic liquids, chemical gases or vapors, or potentially injurious light radiation. STANDARDS Manufacturers are required to comply with federal regulations, but they also voluntarily strive to meet industry quality standards developed by the ophthalmic section of the American National Standards Institute (ANSI). Several ophthalmic ANSI standards address eyeglasses and sunglasses. The standard that covers Rx eyeglasses is ANSI Z80.1, Prescription Ophthalmic Lenses – Recommendations (2015). It details recommendations for prescription dress ophthalmic spectacle lenses

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